AMVETS Jobs

Job Title: Regulatory Operations Intern Req ID: 41447 Job Category: Intern Mentor, OH, US, 44060 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary The Corporate Regulatory Department is looking for energetic, dynamic and team-oriented individuals to complement our group's mission to diligently execute critical compliance initiatives. This dynamic role will provide exposure to many of the regulations, standards, and practices that define the regulatory landscape and govern the medical device industry, which may include yet not be limited to: * 21 CFR Part 820 - FDA's Medical Device Quality System Regulations (QSR) * 21 CFR Part 11 - Electronic Records, Electronic Signatures * 21 CFR Part 830 - Unique Device Identification * Global Unique Device Identification Database (GUDID) Guidance for Industry * FDA Premarket Notification 510(k) * FDA Establishment Registration and Device Listing * FDA's Medical Device Databases * European Council Directive 93/42/EEC for medical devices * European Medical Device Regulation (MDR) * ISO 13485:2016 Medical devices - Quality management systems * ISO 9001:2015 Quality management systems Duties The intern is expected to learn and carry out tasks as assigned that will: * Support the maintenance and enhancement of Corporate Regulatory policies and procedures * Assist in collecting and organizing information on Regulatory SharePoint And TEAM sites as needed * Assist with the collection of labels and product information needed for the submission of UDI information to the FDA and Global Data Synchronization Network (GDSN) for compliance with U.S., U.K and EU UDI requirements. * Assist senior Regulatory Affairs staff as assigned in writing, formatting, researching, compilation, cross-checking, eCopying, submitting, and generating appropriate responses to FDA requests * Assist with the dissemination of supplier notifications for UDI, collection of responses and maintenance of documentation * Maintain department records of medical device assessments and regulatory submissions * Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized * Conduct daily activities of assigned job responsibilities and projects as assigned * Support a safe, clean and secure working environment by supporting procedures, rules and regulations * Utilize Excel and Powerpoint to prepare and present progress reports Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies Required Experience Education Requirements Currently enrolled in college with a major in science, engineering, regulatory, internal audit, premed, legal, or general business core concentration. Experience, Knowledge or Skills * Proficient in Microsoft Word applications, including Word, Excel, PowerPoint and Outlook * The following competencies are critical for this position o Strong learning agility o High energy o Resourceful o Team oriented o Excellent communication skills (written and verbal) o Analytical thinker o Well-organized o Attention to detail and quality STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers